Quala Topical Anesthetic Gel
NDC Package 43128-034-30

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Quala Topical Anesthetic Gel (benzocaine) gel is apply only amount needed to the oral mucosa to prevent or relieve pain.children under 2 years of age: do not use. This formulation utilizes a gel delivery system. Marketed by National Distribution & Contracting, Inc, this product is identified by NDC 43128-034 and is authorized under FDA application M022.

Identification & Billing

NDC Package Code
43128-034-30
Package Description
30 g in 1 JAR
Product Code
43128-034
11-Digit Billing Format
43128003430
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Quala Topical Anesthetic Gel
Non-Proprietary Name
Benzocaine
Substance Name
Benzocaine
Dosage Form
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
Administration Route
Dental - Administration to a tooth or teeth.
Active Ingredient(s)
BENZOCAINE 200 mg/g
Pharmacologic Class
Usage Information
Apply only amount needed to the oral mucosa to prevent or relieve pain.children under 2 years of age: do not use

Regulatory & Marketing

Labeler Name
National Distribution & Contracting, Inc
Product Type
Human Otc Drug
FDA Application #
M022
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
10-01-2019
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 43128-034-30 identifies a specific commercial package of 30 g in 1 jar of Quala Topical Anesthetic Gel, a human over the counter drug labeled by National Distribution & Contracting, Inc. This gel is formulated for dental use and contains benzocaine as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by National Distribution & Contracting, Inc on October 01, 2019. The current certification is valid through December 31, 2027.

How is this National Distribution & Contracting, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43128003430. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
43128-034-30
11-Digit CMS (5-4-2)
43128-0034-30

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.